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cap-ONE YG-221T

by Nihon Kohden Corporation

Part of a family of 24 devices: see the family page

Ref YG-221T

cap-ONE YG-221T is a Class I device made by Nihon Kohden Corporation, registered in EUDAMED on 15 May 2026 (Basic UDI-DI 4931921MD10022BF) and listed in FDA GUDID since 22 May 2023 (UDI-DI 14931921010270), active as of 12 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4931921MD10022BF Basic UDI-DI 14931921010270UDI-DIDate15 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number14931921010270 UDI-DI Date22 May 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4931921MD10022BF registered 15 May 2026 Active
  • FDA GUDID UDI-DI 14931921010270 listed 22 May 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 14931921010270
  2. Registered EUDAMED 4931921MD10022BF

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Adult cap-ONE Nasal Adapter YG-221T EUDAMED
cap-ONE GUDID
Generic name
Carbon dioxide monitor
Device name
Patient monitoring system module, carbon dioxide
Model / Ref / Catalog
YG-221T
Primary DI / UDI-DI
14931921010270
Basic UDI-DI
4931921MD10022BF
FDA product code
BZA, CAT
EMDN code
Z1203020485 Gaseous exchange monitoring instruments - consumables
GMDN term
Carbon dioxide monitor
Device class
Class I
Regulation number
868.5810, 868.5340
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Related devices

Category: Carbon dioxide monitor

Similar devices in this category

Other devices filed under GASEOUS EXCHANGE MONITORING INSTRUMENTS - CONSUMABLES.

Other devices from Nihon Kohden Corporation

See all devices from Nihon Kohden Corporation →

Properties

  • Single use
  • Measuring function
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)